D
EEL
2:
RESULTATEN
presentaties projecten 2019 voorbereid voor
op de diensthoofdenvergadering 16-03-2020
065 279770
2.1. INLEIDING
Introduction to the report from 01/01/2019 to 31/12/2019 from Dr. Vincent
Remouchamps
CONTEXT
Peer review, Quality Oriented, Nomination by health minister, volunteers,
activities financed by FOD/SPF also via Cancer Plan
Current members
o Xavier Geets, UCL St Luc
o Nico Jansen; CHU Liège
o Yolande Lievens, UZ Gent (vice-president)
o Maarten Lambrecht, KUL Leven (secretary)
o Luigi Moretti, Bordet
o Vincent Remouchamps, CHU Namur (president)
o Karin Stallemans, Kortrijk
o Reinhilde Weytjens, Iridium, Antwerpen
With many experts (physics, doctors, RTT, Quality managers)
Collaborotion with
o FANC-AFCN (norms), BeStRO, KCE-RIZIV-INAMI, Belgian Cancer
Registry (BCR)
MAIN ACTIVITIES
Audits (clinical, physics, nurse/RTT, quality system): coordination by Prof
Scalliet
o Peer review of all Belgian Radiotherapy Departments
o Done by pairs, volunteers, reimbursed of costs
o Multidisciplinary (doctor, physicist, nurse/RTT, quality manager)
o Based on the IAEA (International Agency of Atomic Energy)
methodology adapted to the Belgian Context (B-Quattro)
o Global and local high quality and continuous improvement is
observed
o Room for improvement is pointed.
o The description of the 2019 activity is in the report
Organ specific projects: Rectum, breast, HN, lung: consensus, delineation
inter-vision: Procalung (Project Cancer of the Lung): Coordination by
Dr Luigi Moretti and Dr Florian Charlier (PhD student), Bordet. Group
includes as well Pr Xavier Geets, Pr Maarten Lambrecht, Dr Vincent
Remouchamps)
o Lung Cancer radiotherapy quality InterVision is the ongoing project
o A consensus guideline for target delineation has been negotiated
and adopted at the Belgian level, based on international consensus
o We were able to demonstrate an improved homogeneity of
o GDPR issues as technical issues have slowed the next phase of
tumor contouring InterVision, at a larger scale, about to start in
2020
o Satellites projects using the college collaborative platform and tools
are emerging, like in the Head and Neck field
o The description of 2019 activities and specificities are in the report
Quality indicators project (Coordination by Aude Vaandering, UCL St
Luc, PhD student, thesis coordinator Prof. Yolande Lievens and Prof. Pierre
Scalliet)
o Structure, process and outcome quality indicators have been
followed longitudinally in all Belgian Radiotherapy departments, for
several years
o High and continuously improved quality is observed
o The description of 2019 activities and specificities are in the report
Physics audits (BELDART) Coordination B. Reniers and Y. Buldach,
Hasselt University
o Dosimetric supervision, independent measures of the dose delivered
by the machines in classical and technically challenging situations
such as stereotactic radiotherapy
o High quality is observed, deviations are checked, discussed,
re-analyzed
o The description of 2019 activities and specificities are in the report
PRISMA RT (incident reports) Coordination Frederik Vanhoutte
o National benchmarking of incidents and near incidents in
radiotherapy
o Based on Prisma methodology and Taxonomy
o Recorded and analyzed in “Patient Safety Company” from Adheco
o The description of 2019 activities and specificities are in the report
Lung , Liver, Paraspinal, others SBRT analysis with Belgian Cancer
Registry and RIZIV-INAMI
o Stereotactic Radiotherapy (high dose in a small volume, few
fractions) is new
o It is promising, likely efficient and safe
o A national database with clinical and technical data is prospectively
used
o The results are excellent with excellent survival at 1 year in early
data
o The analysis is ongoing
Radiation for benign diseases
o A national inquiry was sent to all departments
o It was based and compared to a previous similar survey
o It shows a drastic decrease of radiotherapy use for benign lesions,
with new indications such as acoustic neurinomas
2.2. AUDITS
COLLEGE DES MEDECINS RADIOTHÉRAPIE-ONCOLOGIE
B-QUATRO audits
Report
VAANDERING Aude
Contenu
1. Introduction ... 2
2. Auditors ... 2
3. B-QUATRO methodology ... 3
4. B-QUATRO audits ... 3
1. Introduction
A first cycle of clinical audits was held in all radiotherapy departments from 2010 till 2015 using the
IAEA QUATRO
1methodology. Upon the success of the first cycle of audits, it was decided to reviewed
and adapt the QUATRO document in order to update some of its elements and to integrate a chapter
focusing on quality management. This modified version of the QUATRO document – called the
B-QAUTRO document is now being used to carry out the second cycle of audits. This has started in 2017
and a total of 14 departments (and their satellite sites) have been audited up until the end of 2019.
2. Auditors
The B-QUATRO auditor team is composed of radiation oncologists (RO), medical physicists (MPE),
nurses and radiographers working in radiotherapy (RTTs) and quality managers (QM).
The updated list of auditors is found here below:
Auditors
Status
RO Auditors
Pierre Scalliet
OK
Paul Van Houtte
OK
Caroline Weltens
OK
Katia Vandeputte
OK
Vincent Remouchamps
OK
Yolande Lievens
R
MPE auditors
Dirk Verellen
OK
Michel Van Dycke
OK
Milan Tomsej
OK
Nadine Linthout
OK
Stefaan Vynckier
OK
Barbara Vanderstraeten
R (for 2020)
RTT auditors
Guy Vandevelde
End 2020
Catherine Meunier
OK
Paul Bijdekerke
OK (end 2019)
Pieternel Thysebaert
OK
Ann Vermylen
OK
Els Goemare
OK
QM auditors
Anitha Batamuriza-Almasi
OK
Nathalie Deman
OK
Frederik Vanhoutte
OK
Séverine Cucchiaro
OK
3. B-QUATRO methodology
As previously mentioned, the second cycle of audits is carried out using the methodology and
checklist described in the B-QUATRO document
2. These audits are carried out in +- 5 departments (+
their satellite sites) per year by a team of auditors composed of 1 RO, 1 MPE, 1 RTT and 1 QM
3and
are mostly carried out between end of October and January depending on the availabilities of the
audited department and the auditors. In order to facilitate the auditing process, a OneDrive account
was set up in order to be able to work and modify the checklist documents in a synchronous manner.
4. B-QUATRO audits
At present, 14 departments (+ their satellite sites) have been audited (see table below).
Year
Department
Auditors
2017
CHU Liège (& CHC Saint Joseph, CHR
Citadelle, CA Vivalia)
P Scalliet/K Vandeputte, M Van Dycke/ S
Vynckier, A Vermeylen/ C Meunier, A
Vaandering/E Blondiau
CHR Verviers
P Scalliet, M Van Dycke, P Thysebaert, E
Blondiau
Limburgs Oncologish Centrum (LOC) –
Campus Sint Jan(ZOL) & Campus Virga
Jesse (Jessa Ziekenhuis)
C Weltens, D Verellen, F Vanhoutte, G
Vandevelde
AZ Turnhout - Campus St Elisabeth
S Derycke, N Linthout, P Bijdekerke, N
Deman
UCL-Namur (Cliniques et Maternité St
Elisabeth & CH Mouscron)
P Van Houtte, M Tomsej, G Vandevelde, A
Batamuriza-Almasi
2018
Iridium Kankernetwerk (St Augustinus,
AZ Nikolaas, Jan Palfijn, Klina)
K Vandeputte, S. Vynckier, G Vandevelde , A
Vaandering
Institut Bordet
S Derycke, M Tomsej, A Vermeylen, A
Batamuriza Almasi
AZ Delta (Roeselare)
C Weltens, N Linthout, P Bijdekerke, N Deman
UZ Leuven Gasthuisberg
P Van Houtte, D Verellen, P Thysebaert, F
Vanhoutte
2019
CHU André Vésale & CHU Tivoli
P Van Houtte, M Van Dycke, C Meunier, A
Batamuriza-Almasi
Grand Hôpital de Charleroi – Site St
Joseph
C Weltens, N Linthout, P Thysebaert, N
Deman
Cliniques de l’Europe – Site Saint
Elisabeth
K Vandeputte, D Verellen, G Vandevelde, F
Vanhoutte
EpICURA – Clinique Louis Cathy
V Remouchamps, M Tomsej, A Vermylen, S
Cucchiaro
UZ Gent
P Scalliet, S Vynckier, P Bijdekerke, E
Goemare, A Vaandering
An auditor meeting will be held on May 15
th2020 in order to discuss the 2019 audits and to plan the
2020 audits.
The planned audits for 2020 and 2021 are theoretically as follows (10 departments):
2020
2021
Onze Lieve Vrouw Ziekenhuis
Clinique Saint Jean
Centre Hospitalier de Jolimont
AZ Sint-Lucas
Cliniques Universitaires St Luc
UZ Brussel (Campus Jette & Algemeen Stedelijk
Ziekenhuis)
AZ Sint- Maarten
AZ Groeninge
CHIREC- Edith Cavell
AZ SInt Jan
5. Global observations made for the 2017 and 2018 audited departments
Following the auditors’ meeting in May 2019, the audit reports were reviewed
4in order to be able to
identify common areas in which recommendations have been emitted.
Department infrastructure and workload
Figure 1 - Departments compliancy rate per global evaluation item of the department infrastructure and workload chapter
Observations:
Overall, all departments seem compliant as to their equipment level.
Recommendations pertaining to personnel have been submitted to all departments except
for one.
Patient related procedures
Observations:
In all departments except one, access to diagnostics is compliant
In all departments there are no recommendations pertaining to patient discussion during
MOCs, immobilisation device use and treatment report quality.
Follow up is pointed out as being partially compliant or non-compliant in all departments
except one.
Note:
Patient follow-up is an area in which departments have difficulty in implementing a formalized
structure
o Follow-up was extensively discussed at the meeting as it is common belief that
Figure 2 - Departments compliancy rate per global evaluation item of the patient related procedures chapter
o It was also observed that the evaluation of this item varied across auditors as a
function of the auditor’s perception of the item and its evaluated elements.
o It is pointed out though that RT patient follow up should not be considered as a
radiotherapy specific issue but should be seen as global oncological issue.
Equipment related procedures
Observations:
Most frequently addressed recommendations concerned imaging equipment
Quality Management system
Figure 3 - Departments compliancy rate per global evaluation item of the equipment related procedures chapter
Observations:
Risk management seems to be the areas were auditors emitted the most recommendations
Insufficiencies pertaining to quality manuals were also the source of emitted
recommendations
Patient satisfaction, on the other hand, was an element that was often well addressed in the
different audited departments
Original Article
Feasibility and impact of national peer reviewed clinical audits in
radiotherapy departments
Vaandering Aude
a,b,⇑, Lievens Yolande
c, Scalliet Pierre
a,b, on Behalf ofthe Belgian College for Physicians in
Radiation Oncology
a
Radiation Oncology Department, Cliniques Universitaires Saint Luc;b
Center of Molecular Imaging, Radiotherapy and Oncology (MIRO), Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, Brussels; andc
Radiation Oncology Department, Ghent University Hospital, Ghent, Belgium
a r t i c l e i n f o
Article history:Received 18 September 2019
Received in revised form 7 January 2020 Accepted 8 January 2020
Available online 7 February 2020 Keywords:
Clinical audits Safety Quality audits
Quality management system
a b s t r a c t
Purpose/objective: A national incentive brought about the instauration of systematic clinical audits of all Belgian radiotherapy departments (n = 25) from 2011 to 2015 using the International Atomic Energy Agency QUATRO (Quality Improvement Quality Assurance Team for Radiation Oncology) methodology. The impact of these audits was evaluated and the emitted recommendations originating from the audit reports were analysed to identify areas of weakness on a national basis.
Method: The QUATRO audits performed in each radiotherapy department gave rise to reports in which each department received a list of recommendations that it is free to implement. These audit reports were analyzed to identify common areas for which improvements were recommended. Moreover, ques-tionnaires were sent to all departments in order to evaluate the overall usefulness of the recommenda-tions as well as the relevancy and the actual impact of each individual recommendation.
Results: Of the 381 emitted recommendations, 34% concerned process optimization of which a quarter involved process improvement and protocol development. Twenty-seven percent of the recommenda-tions concerned infrastructure of which one-third was related to the quality of the equipment or facility. Nineteen and 20% of recommendations addressed department organisational and staff issues respec-tively.
When analysing the departments’ feedback questionnaires, 54% of the departments evaluated the audits’ recommendations as being very useful. Furthermore, 42.7% of the recommendations were found to be very relevant and 23.5% were deemed to have an important impact.
Conclusion: This first round of audits in Belgium allowed for the identification of common areas for improvements of practice in radiation oncology departments, with a focus on process optimization and infrastructure elements. Similarly, the audits’ emitted recommendations were globally deemed very relevant. Encouraged, by this analysis, a second cycle of audits has started in Belgium with a modified version of the QUATRO document (B-QUATRO).
Ó 2020 Elsevier B.V. All rights reserved. Radiotherapy and Oncology 144 (2020) 218–223
In 1997, EURATOM issued a directive (97/43) requiring member states to organize clinical audits in radiotherapy. The European Medical Exposure Directive of 2013 (Council Directive 2013/59/ Euratom), further defined clinical audits as ‘‘a systematic examina-tion or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where appropriate, and the application of new standards if necessary”. These two consecutive
directives required Member States to ensure that clinical audits are carried out according to national procedures (to be developed), with a mandatory transposition into national legislation by Febru-ary 2018[1]. In Belgium, the 97/43 directive was transposed in a Royal Decree in 2002 and the mission to carry out clinical audits was implicitly entrusted to the newly founded College for Physi-cians in Radiation Oncology.
The potential benefits of clinical audits are multiple with the overall aim of achieving continuous quality improvement through the implementation of corrective actions based on the recommen-dations emitted by the audits. Moreover, in healthcare, quality
Radiotherapy and Oncology 144 (2020) 218–223
Contents lists available atScienceDirect
Radiotherapy and Oncology
role in identifying areas of risk and promoting preventative mea-sures[2].
The International Atomic Energy Agency (IAEA) published a document in 2007 entitled ‘‘Comprehensive Audits of Radiother-apy Practices: A Tool for Quality Improvement” which proposes a methodology to carry out comprehensive clinical audits in radio-therapy[3]. This clinical audit focuses on the entire radiotherapy process and evaluates aspects such as the organisation, infrastruc-ture, clinical and physical elements underlying a radiotherapy department. This audit is a peer review process undertaken by an audit team composed of a radiation oncologist (RO), a medical physicist (MP) and a radiation therapist (RTT). Known as IAEA QUATRO (Quality Assurance Team in Radiation Oncology) audits, this audit methodology has been conducted in over 77 radiother-apy departments located in Europe, Latin America, Asia and Africa
[4,5].
In Belgium, it was decided to use the IAEA QUATRO methodol-ogy to carry out clinical audits in all radiotherapy departments. As such, a first cycle of audits took place in the 25 Belgian radiother-apy departments over a five-year period (2011–2015). The depart-ments’ perception of the relevance and actual impact of the recommendations emitted by the audit has been evaluated after-wards (2016). It was also of importance to review the recommen-dations in general in order to identify possible areas of improvement on a national basis. The aim of the present work is to report the results of the analysis of this first cycle of Belgian IAEA QUATRO audits.
Materials and methods QUATRO audits in Belgium
Following the publication of the 2002 Royal decree, which translated the 97/43/Euratom directive into Belgian law, it was a shared opinion that neither the Belgian Ministry of Health nor the radiation protection regulatory body (Federal Agency of Nuclear Control (FANC)) had the human and financial resources necessary to implement clinical audits on a national basis[6]. Fol-lowing multiple meetings between the involved parties, it was decided that the Belgian College for Physicians in Radiation Oncol-ogy would organize these audits on its own limited budget. This commission is composed of Radiation Oncologists (RO), appointed by the Ministry of Health and assisted by external experts such as medical physicists (MP) and RTTs. Its mission is to promote the quality of radiotherapy on a national level. It was decided that the IAEA QUATRO audit methodology was the most convenient solution to carry out these audits. QUATRO is an internationally validated tool whose peer review based methodology was consid-ered to be in line with the vision of all involved parties[6]. More-over, some members of the College were already active IAEA QUATRO auditors themselves. As such, a core group of 15 RO, MP and RTT auditors (5 per discipline) was trained during a two-day seminar in 2011 and the first audits were carried out by teams mixing composed of newly trained and experienced auditors. The audits themselves were organised in such as manner as to audit 5 departments/year over a 5-year period (2011–2015). Each audit was carried out over 3 full consecutive days, as opposed to the 5-day audits proposed by the IAEA due to feasibility and efficiency reasons. The audits in Belgium solely focused on external beam
tions that the department was encouraged to implement. These reports were sent to the department within a limited time frame from the audit itself. In parallel, on a yearly basis, an anonymized report summarizing the results of the audits was sent to the Min-istry of Health.
Emitted recommendations analysis
In the present analysis, all recommendations were extracted from the individual audit reports and loaded in an Excel spread sheet. The recommendations were then categorized according to a 3-level taxonomy system as described by Izewska et al.[4]. The first category level uses four main divisions to classify recommen-dations into issues pertaining respectively to (1) staffing, (2) infras-tructure, (3) process or (4) organisational factors. The second category level is then used to delve further into the four broad cat-egories and the third level categorization is intended to provide even further differentiation. As such, each recommendation was assigned a 3 level classification code (seeTable 2).
Using this taxonomy, it was possible to classify the emitted rec-ommendations and as such obtain a global view of the proportion of emitted recommendations that have been forwarded by the audits.
Audit feedback
Following the first 5-year cycle of audits, it was important to evaluate the audited departments’ perception of the audits. A per-sonalized Excel (Excel 2010) based questionnaire was sent in 2016 to each department’s head RO and quality manager and in which the radiotherapy team was asked (1) to evaluate the overall per-ceived usefulness of the audits and (2) to evaluate the relevance and (3) actual impact of each individual recommendation that was addressed to their department following the audit. The respondents were asked to evaluate these different elements using a 5-point ordinal scale ranging from not useful/not relevant/no impact to primordial usefulness/primordial relevance/primordial impact (seeTable 1). For analysis purposes, these scores – although ordinal – were considered as continuous variables in order to eval-uate the mean scores.
The departments were asked to provide feedback within one month of having received the questionnaires. The completed ques-tionnaires were then analysed on a department and national level. Further analysis was carried out in order to evaluate the possible correlation between the type of recommendation emitted (as a function of the proposed IAEA categorization code) and its per-ceived usefulness and impact. In other words, we tried to estimate if the type of recommendation ((1) staffing, (2) infrastructure, (3) process or (4) organisational recommendation) had an influence on the scores attributed to the recommendation in the question-naire. Statistical tests (Generalized mixed models – Multinomial logistic regression) were performed using SPSS 25.0 for Windows (IBM corp., USA).
Results
Twenty-five departments were audited during this first cycle of audits carried out between 2011 and 2015. Overall, these audits demonstrated a good and harmonious level of quality of
and 20% and 19% of recommendations addressed organisational and staff issues respectively. The level 1 and level 2 classifications of the recommendations are illustrated inTable 2.
Of the process recommendations, one quarter concerned the overall optimisation of the clinical process and the development of Standard Operating Procedures (SOP) impacting multiple clinical processes (i.e.: optimisation of hygiene procedures, harmonisation of treatment techniques). Fourteen percent related to the treat-ment planning process and highlighted the need to increase the number of verifications that are carried out (i.e.: independent ver-ification of generated treatment plans). Fifteen percent concerned the treatment verification/imaging process and mostly pertained to ameliorating Image Guided Radiotherapy (IGRT) procedures (i.e.: use of online co-registration).
One-third of the recommendations targeting infrastructure focused on structural features of the facility and the treatment machines (i.e.: accessibility and layout of the department, age of the equipment). A little less than 10 % of infrastructure recommen-dations focused on the need to increase the quality control proce-dures on the immobilisation systems, as a great majority of departments do not carry out regular checks on the immobilization equipment.
The recommendations focusing on the department organisa-tional aspects were mostly addressing issues pertaining to the development of organisational charts (or lack thereof), the instau-ration of a paperless environment as an additional system of pro-tection against the propagation of mistakes and the amelioration of feedback concerning incidents and near-incidents. It is also important to note, that 13.3% of the organisational recommenda-tions concerned the lack of systematisation of patient follow-up.
Finally, 37.8% of the recommendations relating to staff focussed on the RTT staff and pointed out the lack of training and profes-sional development accessible to this profesprofes-sional group. The lack of communication within and across disciplines amongst all staff was also pointed out in 15% of the recommendations.
As previously mentioned, audit follow-up questionnaires were sent to all departments. Twenty-two out of the 25 audited depart-ments responded to these questionnaires. Of the three missing departments, one did not officially respond as, in the meantime, it had merged with another department to become a single department.
Fifty-four percent of the departments evaluated the audit’s
rec-was deemed to be moderately relevant. Conversely, those recom-mendations pertaining to staff, process and department organisa-tional matter were most frequently scored as being very relevant (45% of recommendations) (Fig. 2). The recommendations’ rele-vancy scores significantly varied from one department to another (p < 0.05). Yet, the type of emitted recommendation did not have an influence on the relevancy score (p = 0.993).
When scoring the actual impact the individual recommenda-tions had on the department, 23.6% were deemed to have an important impact, while the largest part was scored as having a moderate impact (30.7%) (Fig. 2). Not unlike the relevancy score, the median overall impact score was evaluated at 2 with a mean score of 1.6 ± 0.4 (Fig. 1). Recommendations deemed to have the most impact were those pertaining to process optimisation. Unlike the relevancy score, the recommendations’ impact score did not vary from one department to another. Nonetheless, as with the rel-evancy scores the type of emitted recommendation did not have an influence on the impact score (p = 0.41) (Fig. 2).
In all cases, the relevancy and impact score were not influenced by the elapsed time that had occurred between the time the department was audited and the time of the questionnaire (p = 0.3 and 0.8 respectively)
Discussion
Peer reviewed clinical audits of radiotherapy departments have been carried in a number of departments using QUATRO[4,5]or other methodologies such as IROCA and locally developed audits
[10,11]. However, the situation in Belgium is unique in that these clinical audits have been successfully implemented on a national basis and identically carried out in all departments, even though variation does exist among different departments (i.e.: number of patients treated, academic or non-academic based department. . .). This underlines the fact that the QUATRO audit can be used in divergent environments and is, as such, a widely applicable methodology.
All 25 Belgian radiotherapy departments have been audited between 2011 and 2015, resulting in the formulation of 381 rec-ommendations, but with the overall conclusion that all radiother-apy department were functioning with a harmonious approach to continuous quality improvement.
As expected, the majority of the recommendations focussed on
Table 1
Likert scales used in the audit feedback questionnaires in which usefulness is defined as the possibility of the recommendations being acted upon, relevancy is the appropriateness of the recommendation and impact is the effect the recommendation has had on the department’s infrastructure, organisational situation and/or clinical practice.
Overall usefulness of emitted recommendations
Not useful Little useful Moderately useful Very useful Primordial Relevancy of individual
recommendations
The recommendation was not relevant to the department’s situation/context
The recommendation was little relevant to the department’s situation/context
The recommendation was moderately relevant to the department’s situation/context
The recommendation was very relevant to the department’s situation/context
The recommendation was primordial to the department’s situation/context Impact of the individual
recommendations
The recommendation had no impact on the department’s organisational/ infrastructural situation
The recommendation had little impact on the department’s organisational/ infrastructural situation
The recommendation had a moderate impact on the department’s organisational/ infrastructural situation
The recommendation had a big impact on the department’s organisational/ infrastructural situation
The recommendation had a primordial impact on the department’s organisational/ infrastructural situation
Attributed score 0 1 2 3 4
Table 2
Classification of different recommendations stipulated in the audit reports: Recommendations have been classified at the 2nd level and regrouped by level one classification as proposed by Izewska et al.[4].
Types of recommendation Proportion of recommendations
Types of recommendation Proportion of recommendations
I. Department Organisation 19,7% III. Process 33,9%
Staff responsibilities 21,3% Multiple clinical processes 24,8%
Programme/service quality 81,3% Checking/verification 12,5%
Programme availability 18,8% Process quality 43,8%
Quality and safety management 20,0% SOPs, protocols and policies 31,3%
Incident learning 16,0% Access 9,4%
Other 16,7% Documentation 3,1%
Programme/service quality 66,7% Treatment planning 14,7%
Programme availability 16,7% Checking/verification 73,7%
Discharge/Follow-up 13,3% Process quality 10,5%
Programme/service quality 50,0% SOPs, protocols and policies 15,8%
Programme availability 40,0% Treatment verification/imaging 14,0%
Resources 10,0% Checking/verification 5,6%
Other 10,7% Process quality 66,7%
Radiation protection and safety 9,3% SOPs, protocols and policies 22,2%
Referrals/admission 5,3% Documentation 5,6%
Culture and patient centeredness 2,7% Quality assurance 10,9%
Research 1,3% Quality and safety management 0,8%
II. Infrastructure 27,0% RT imaging for planning 9,3%
Facilities 33,0% Treatment delivery 7,8%
Quality of facility or equipment 91,2% Treatment prescription 6,2%
Other 5,9% Immobilization/beam modifiers/patient
marking
4,7%
Opening hours 2,9% Other 3,9%
Treatment machines 19,4% Informed consent 2,3%
Equipment quality control 25,0% Patient work up 0,8%
Quality of facility or equipment 30,0% IV. Staff 19,4%
Equipment complement 25,0% RTT 37,8%
Other 15,0% Training and professional development 39,3%
Maintenance 5,0% Communication within and across
disciplines 3,6% Immobilization/beam modifier/applicators/mould room 14,6% Complement 21,4% Distribution 14,3%
Equipment quality control 66,7% Education 7,1%
Quality of facility or equipment 26,7% Other 10,7%
Equipment complement 6,7% Remuneration/Recognition 3,6%
RT imaging 11,7% All staff 27,0%
Treatment planning system 8,7% Training and professional development 30,0%
Dosimetry 5,8% Communication within and across
disciplines
55,0%
Other 3,9% Complement 10,0%
RT data management system/R&V 2,9% Distribution 5,0%
Radiation oncologist 12,2%
Other 12,2%
Medical physicist 10,8%
Fig. 1. Recommendations’ relevance (left) and impact (right) median score as evaluated per department.
A significant amount of those recommendations also focused on the hierarchal position of the quality managers within the hospital. Indeed, since the advent of the National Cancer Plan in Belgium, each radiotherapy department has received the financial support to hire one full time equivalent (FTE) quality manager (RT-QM) within its department. Practically speaking, RT-QMs come with dif-ferent backgrounds although a majority do have a radiotherapy background (MP or RTT). As such, there is tendency to position these under the hierarchal responsibility of the head RO or head MP. Yet, good practice stipulates that a QM – in order to best prac-tice its functions – should hierarchically be independent of the radiotherapy department.
It is worthwhile to mention that fewer recommendations were formulated relating to quality management system implementa-tion than in other publicaimplementa-tions [4,5], which could partly be explained by the presence of one RT-QM in every radiotherapy department. It is important to note, though, that sixteen percent of the organisational recommendations highlighted the need to improve feedback of declared near-incidents and incidents to the department.
A significant number of recommendations (13.3%) addressed the lack of systematisation in patient follow-up after radiotherapy delivery. These mostly pertained to the lack of formal policies, specifically for high-risk patients, but also underline the necessity of using formal scores for acute and late toxicities follow-up. An alternative approach that could be introduced to tackle this issue is the use of surveillance programs directed by patient symptoms (Patient Reported Outcome Measurements (PROMs)). These would formalize the scores used as well as identify patients who experi-ence significant side effects compared to those that do less and do not necessity require formal face-to-face radiotherapy follow-up with the RO[13–16]. Acute and late toxicity follow-up and clin-ical impact of radiotherapy treatment modalities are essential ele-ments to monitor, amongst others, the ‘‘quality” of radiation treatments. This has been recognized by the College of Physicians in Radiation Oncology which, through the implementation of a national Quality Indicator project, aims at standardizing the collec-tion of toxicity data on a nacollec-tional level, while quantifying the qual-ity of radiation treatments.
The recommendations focusing on staff were mostly addressed
the exception for 50 hours of radioprotection training). Although school-based or national society-based training programs have been developed to tackle this issue, the absence of a legal frame-work to encourage formal RTT training and continuing education remains a weak point in the education of Belgian RTTs.
Following the first cycle of audits, it was deemed of impor-tance to obtain the audited departments’ feedback of the useful-ness, relevancy and potential impact of the audits. Without this feedback, the potential benefits of the audit might have been overlooked. The departments’ feedback actually demonstrated that the audits were considered to be overall useful and that the resulting recommendations were, in the majority of cases, very relevant to the department. The actual impact of the emitted recommendations obtained a lower score. Indeed, an important number of clinical processes and clinical practices cannot be com-pared to formal standards and are, as a result, comcom-pared to what is considered to be ‘‘best practice”. This means that there exists a certain level of subjectivity in the auditing process which can be and was indeed questioned by different entities. The actual impact of a clinical audit can therefore be influenced by factors such as how the audit is perceived by the audited department or hospital management. This can be further influenced by the actual quality of the feedback and report given by the auditors, but also by the establishment of a clear (and feasible) action plan by the department itself[17,18]. As such, the recommendations have to be used by the department in a quality improvement set-ting, in which an action plan is determined, put into place, eval-uated and adjusted for[19,20].
The comprehensive, clinical and ‘‘patient-oriented” character of the QUATRO audits confers undeniable advantages. But it is also important to recognize that clinical audits need to evolve in accor-dance with changing practice and changing standards of care. It has become apparent, over the five-year auditing cycle that treat-ment modalities and treattreat-ment techniques greatly evolve over time. Within this context, it was decided to suspend the audits between 2015 and 2016 in order to review the existing QUATRO tool taking into account the Belgian context, the evolution of stan-dards of care and the facilitation of the auditing process. In addi-tion, an internal initiative of the association of the Belgian RT-QM highlighted the need for developing certain parts of the
QUA-Fig. 2. Distribution of the relevance [left] and impact [right] score as a function of the level one classification of the emitted recommendations. 222 National clinical audits in radiotherapy departments
In conclusion, peer-reviewed clinical audits based on the QUA-TRO methodology have been successfully implemented in Belgium with all radiotherapy departments having been audited between 2011 and 2015. Revisions of the emitted recommendations stated in the audit reports have allowed the auditors to encourage depart-ments to optimize their clinical practice but also to identify some elements needing to be improved on a national basis. These include increasing the training level of the RTTs, enhancing the feedback and communication related to incident reporting, devel-oping formal follow-up systems for radiotherapy patients and ini-tiating quality assurance programs for immobilisation equipment. When obtaining feedback from these audits, the majority of the departments evaluated the recommendations as being very useful and relevant. However, the global impact on the department’s organisational and infrastructural situation was slightly lesser val-ued, partly due to factors outside of the department’s control.
Encouraged by this analysis, a second cycle of audits has started in Belgium with a modified QUATRO document (B-QUATRO). Conflicts of interest
All the authors declare they have no conflict of interest. Acknowledgements
We thank Aurélie Bertrand and Nathalie Lefèvre from the UCL – Statistical Methodology and Computing Service (SMCS) for their support in the analysis of the data.
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ProCaLung Status Report
March 16, 2020
Florian Charlier
On behalf of the College of Physicians for Radiotherapy
ProCaLung team: Y. Lievens, V. Remouchamps, X. Geets, M. Lambrecht and L.
Moretti
In partnership with
RT CENTER
Plan
Summary of the project
Materials and methods for participating centers
Ethics and Regulatory settings
Legal aspect
Practicalities to start
What is ProCaLung
Initiative of the College of Physicians for Radiation Oncology
A national
Quality Assurance
program for
Stage III NSCLC chemoradiotherapy
Offering a
centralized peer review for mediastinal nodal CTV
Aiming for
The evaluation of the
quality of the treatments
in Belgium
The
standardization
of the
mediastinal target volume definition
and
delineation
In collaboration with the
Belgian Cancer Registry
Specific project such as « innovative radiotherapy » to collect most clinical data
RT CENTER
Rationale (1/2)
Latest
ESTRO ACROP guidelines
1:
Suggest to apply this
algorithm
2to define mediastinal
nodal GTV
But is it applicable in practice by
radiation oncologists today ?
Rationale (2/2)
Latest
ESTRO ACROP guidelines
:
different mediastinal CTV delineation methods
Include the
whole station
or the
involved node
Size of the GTV to CTV
margin
Or even neighboring
elective stations
Personal quick adaptation
ProCaLung:
GTV + 5mm
CTV
RT CENTER
Scope - Like PROCARE and PROCAB ?
Yes, there will also be a
consultative peer review
of
target volume
But there will be feedback on
Target definition
: What are the nodes to include in GTV based on the algorithm
Selective-only delineations
, based on target definition and ProCaLung recommendations
And
patient data collection
to
evaluate
the
impact of target volume
on
Toxicity
Disease control
But it is also a
quality assurance
project
, collecting patient data
to
Evaluate the
quality of delivered treatments in Belgium
Materials
Inclusion for 2 years, of patients with
Inclusion criteria
Histologically confirmed
NSCLC
Stage III
with
positive mediastinal nodes
Must have
PET/CT staging
Curative intent
radiotherapy ≥ 60Gy
(EQD2)
Chemotherapy
: sequential, concurrent (± induction)
or without
RT CENTER
Materials
Exclusion criteria
Prior history of
thoracic RT
Malignant
pleural effusion
History of malignancy in the last 3 years
,
except basal-cell skin cancer and intraepithelial
neoplasia
Progression
after induction chemotherapy
Use of
concurrent targeted, immunomodulating or anti-angiogenic agents
except if the patient
is included in a clinical trial
Patient refused inclusion
Materials
Dataset to report, if available, before sending the delineations
Histological
diagnosis, tumor localization
and
cTNM
Reports of
staging procedures (CT, PET, E(B)US, pathology, MOC)
Used for review
Must be
anonymized
(no name, no date, no address)
A character recognition software will be provided to capture text from images/pdf files
History and active
smoking
status
ECOG
performance status
Previously
delivered
systemic treatments
RT CENTER
Materials – Target definition
Dataset to report, for review
What nodes does the radiation oncologist
identify as
positive based on CT and PET
images and pathology reports ?
Materials – Target definition
Dataset to report, before review
What nodes does the radiation oncologist
identify as
positive based on CT and PET
images and pathology reports ?
What the radiation oncologist chose to
include in nodal GTV
RT CENTER
Target definition – Inclusion in nodal GTV
Materials
And
DICOM
files
Planning CT + RT structures, PET/CT, if available, (before chemotherapy)
RT CENTER
Reviewing Methods
Review will be performed by one RTT and validated by a physician
Target definition review
can
Be
impossible
for some reasons : Missing reports, unprecise reports, etc..
Be
equal
to what the RT center chose to include in GTV.
Be
different
from what the RT center chose to include in GTV. Delineations review is
based on ProCaLung guidelines
ProCaLung will give this information and where are the differences, if applicable
RT CENTER
Target Definition
What is
positive
on
imaging
Report (CT or PET)
Radiation Oncologist Comment
ProCaLung
Positive
Positive
Straightforward
Positive
Clearly negative
Negative
Straightforward
Negative
Positive
Uncertain
Role of specialist
Positive
Clearly negative
Uncertain
Role of specialist
Negative
Positive
Negative
How often ?
N/A
Clearly negative
Positive
How often ?
N/A
Not clear, n.a.*, or uncertain
Positive
How often ?
N/A
Not clear, n.a.*, or uncertain
Negative
How often ?
N/A
Not clear, n.a.*, or uncertain
Uncertain
How often ?
N/A
* Report is not available
RT CENTER
Materials & Reviewing Methods
ProCaLung review will consist of the application of its recommendations:
CTV =
GTV + automatic isotropic 5 mm
margin,
cropped
to
OAR
and
anatomical boundaries
,
extending to
include all partially delineated nodes
. This also applies to pre-chemotherapy
volumes.
And giving
feedback
, for GTV and CTV, on
Where the RT center’s
delineations
were
more than 3 mm away from ProCaLung’s
Whether
more than 5% of the surfaces
are
more than 3 mm away from one another
(95
thpercentile Hausdorff Distance)
RT CENTER
Materials – Start of treatment
Dataset to report, at the start of treatment
Target definition, if changed
since initial upload
Treatment technique
RT prescription
:
Up to 4 prescription points, e.g And DICOM files: final RT structures, RT plan, RT dose
Structure name Total dose (Gy) Structure volume (%)
Number of fractions
Step (if sequential plans)
PTVn
60
50
30
1
PTVn
57
95
30
1
RT CENTER
Materials – End of treatment
Dates
of
first and last fraction
,
number of fractions
delivered
Was an
adaptive
plan
delivered?
If yes,
how many fractions were delivered with the first plan
before treating with that plan?
+ New
DICOM
files: CT, RT structures, plan and dose
Concurrent systemic treatment
delivered, for each regimen (if any)
Date of first cycle, Molecule(s), Number of cycles
Grade 3+ acute toxicity during treatment
Esophageal, Pulmonary, Other to specify
Materials – Follow-up at 3 and 12 months
[Was
a systemic treatment
given after the end of RT as
consolidation
? Which one?]
Grade 3+ acute toxicity
after the end of radiotherapy treatment
Esophageal, Pulmonary, Other to specify
If the patient
relapsed
Date
of first examination showing clear progression, or MOC.
Localization
: Local within/outside the CTV, locoregional within/outside CTV, distant
Is it an
isolated nodal failure
?
Is the patient
alive
? If not, date of death
RT CENTER
Ethics and Regulatory settings
This project is a
registry
, collecting data for
Quality Assurance
It includes a
peer review activity,
as it is the history and mission of the College
The College can
initiate
this type of project, which is
not a clinical trial
As provided by the
GDPR
, and transposed into Belgian Law
,
for public interest and
scientific data processing, we will work on
pseudonymized data
,
without having the
conversion table
and
without explicit patient consent
Therefore,
ProCaLung
will
never be able to know
whose data is provided or who is included or
not
The BCR will know, of course, as provided by a specific Belgian Law
Ethics and Regulatory settings
ProCaLung
does
not choose or intervene on the treatment
a patient will have, at all
This means that the patient’s
radiation oncologist only chooses if and how he/she uses
the given feedback
for target definition and delineations
RT CENTER
Ethics and Regulatory settings
ProCaLung has been submitted to the IJB Ethics Committee (CE3128)
The
project, protocol and information for patients will be publicly available
on
www.procalung.be
NB: A patient who decides to be excluded from ProCaLung will contact their
physician or department who will contact us with the ProCaLung ID to close their
file.
Ethics and Regulatory settings
Each center must provide the information to the patients
General
patient information documents
,
website
,
brochure
and/or
display
in the RT center:
“ This institution/department participates to the quality assurance project for
lung cancer radiotherapy ProCaLung (patient information on
www.procalung.be
)
All documentation for patients will be available on
www.procalung.be
A
template document
has been prepared and submitted to the ethics committee. (also
on website)
RT CENTER
Legal aspects
An agreement will be set between the College and each participating institution to
Confirm participation
Cover GDPR requirements (data transfer agreement).
Practicalities to start
Users must be configured for Aquilab use
Please send information of 2 users for your center who will encode on their platform:
Name, role and email To procalung@bordet.be
Users must be configured for Belgian Cancer Registry use
To be configured in your institution with the IT department to “activate” the encoders
NISS is required to allow access with eID.
RT CENTER
Legal aspects to review / approve
Agreement between the College and IJB
Contract between the College and Aquilab (approve review to send to Aquilab)
Agreement between the College and the Belgian Cancer Register
Agreement between the College and Participating RT Centers
Documents to patients (yet to be translated then put on website)
Patient refusal document proposition. To be available on website ?
Next step ?
The current project is
different from the clinical trial setting
In
that
situation, which we might launch in a year
The patients will be treated (and staged?) following ProCaLung’s guidelines, this is the
intervention.
Patients could be randomized, then may be necessary to be multinational (depending on
objective and endpoints)
Patients will be counseled and will have to give informed consent
There will be more rigorous monitoring (QA), longer follow-up, less optional data in favor of
College QI project
National report
VAANDERING Aude
aude.vaandering@uclouvain.be
16/12/2019
National QI data for radiotherapy
departments
(2018)
College QI project
Content
A
BBREVATIONS USED... 2
C
ORRECTIONS/
COMMENTS MADE SINCE2017
QI
REPORT... 3
I
NFRASTRUCTUREQ
UALITYI
NDICATORS... 4
G
ENERAL INFORMATION... 4
E
QUIPMENT DATA... 4
EBRT
EQUIPMENT AVAILABILITY AND FUNCTIONALITIES... 4
T
REATMENT ACTIVITIES... 5
EBRT
ACTIVITIES(
EXCLUDINGIORT) ... 5
I
NTRAOPERATIVE RADIOTHERAPY(IORT)
ACTIVITIES... 9
B
RACHYTHERAPY(BT)
ACTIVITIES... 10
H
UMAN RESOURCES... 11
P
ATIENT PROCESS AND OUTCOME QUALITYI
NDICATORS... 13
G
ENERAL INTRODUCTION... 13
B
REAST CANCER PATIENT(
BREAST POST-
OP/
NO NODALRT/
EXCLUDING BILATERALRT
AND PARTIAL BREAST IRRADIATION) . 13
P
ROCESS INDICATORS... 13
O
UTCOME INDICATORS... 16
P
ROSTATE CANCER PATIENT(
EXCLUDING PATIENTS WITH PROSTATECTOMY AND PATIENTS BENEFITING FROMBT
TO TARGET VOLUME) ... 17
P
ROCESS INDICATORS... 17
O
UTCOME INDICATORS... 21
H&N
CANCER PATIENT(
EXCLUDINGT1N0
G
LOTTIS) ... 22
P
ROCESS INDICATORS... 22
O
UTCOME INDICATORS... 26
College QI project
Abbrevations used
Abbreviations used
BT:
Brachytherapy
EBRT:
External Beam Radiotherapy
FTE:
Full Time Equivalent
IORT:
Intra-operative Radiotherapy
MPA:
Medical Physics Assistant
MPE:
Medical Physics Expert
QM:
Quality Manager
RO :
Radiation Oncologist
College QI project
Corrections/comments made since 2017 QI report
With the feedback of some departments following the publication of the 2017 QI report, some changes have
been made in the data presented in the 2017 report. Due to the anonymous nature of the report, the changes
cannot specifically be mentioned however it included a change in:
Imaging capacity of one department
Error in reported elapsed days for one breast treatment for one department
Errors in figures pertaining to workload per professional group for 7 departments
Error in reported brachytherapy activities for one department
College QI project
Infrastructure Quality Indicators
General information
The 2018 infrastructure QI dataset includes the data of 24/24 primary radiotherapy department although
activity data of one department is missing. Indeed one depatmrnt was in the process of moving from one
hospital to another and does not have the complete dataset. The data of all satellite sites except one have
been included.
Equipment data
EBRT equipment availability and functionalities
Table 1 - Number of EBRT equipment available per department (2018) (excl IORT)
Total
Brussels region
Walloon region
Flemish
region
Mean number of EBRT
devices/primary hospital*
3,8
3,7
3,6
4,0
Mean number of EBRT
devices/hospital site
2,5
2,7
2,0
2,7
Mean number of EBRT
devices/satellite
1,4
1
1,2
1,7
* The equipment of the two satelites sites located in regions other than that of their primary hospital, were inluded in the mean number of EBRT devices of the primary hospital’s region (= Brussels region).
